Patient compliance with a prescribed regimen of taking orally administered drugs is necessary for effective treatment. However, this compliance is often adversely affected by drugs which are not palatable. Reduced compliance can also occur with a pediatric or geriatric patient who will not or cannot swallow solid tablets. Similar difficulty can occur in veterinary treatment in that animals can be uncooperative about taking the drug in tablet form.
Conventional forms of drugs for oral administration include direct compression tablets, sublingual tablets, spray congealed powders and triturate tablets. These forms, however, do not provide the advantage of the present specific tablet triturate of this invention.
Tablets which are formed by direct compression are ill suited for the rapid administration of drugs in that compressed tablets do not disintegrate or dissolve fast enough. Furthermore these tablets are difficult for certain patients to swallow.
Sublingual tablets are designed for rapid administration of medication and are placed beneath the tongue and held there until absorption of the drug has taken place through the mucous membranes. These tablets do not improve patient compliance in the above described problem areas, however. Inasmuch as the tablet is absorption in the buccal cavity, an unpalatable sensation is experienced by the patient. In the case of an infant, or psychiatric patient, the patient may also spit the tablet out.
The process of spray congealing involves cooling (or congealing) of melted substances in the form of fine particles during their travel from a spray nozzle to a distant vicinity of a spray chamber held at a temperature below the melting temperatures of the substances. If a slurry of material insoluble in the melted mass of a congealing substance is spray congealed, the insoluble material is coated with the congealing substance. This method provides taste masking. However, this process does not provide tablets for ease of oral administration of the drug. Furthermore, the congealing substance is usually a fatty acid or monoqlycerides, diglycerides, or triglycerides of edible fatty acids.
Trituration is the mixing of powders using a qrinding action, such as by a mortar and pestle, followed by moistening of the powders. This moistened powder is then molded into tablet form and dried. Tablets thus produced do not exhibit taste masking characteristics.
The present invention provides a solid pharmaceutical dosage in tablet triturate form which avoids the shortcomings of the prior art and is both readily dissolvable and masks the taste of the active ingredient.